Spinal Manipulation For Menstrual Symptoms and Sleep in Individuals With Primary Dysmenorrhea

NCT06673537 | Completed

• 1 other identifier: 2024/208
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this observational study is to evaluate if spinal manipulation (SM) combined with connective tissue massage (CTM) improves pain, menstrual symptoms, depression levels, and sleep quality in women with primary dysmenorrhea (PD). The main questions it aims to answer are: Null Hypothesis (H0): SM has no effect on primary dysmenorrhea symptoms, pain severity, depression levels, or sleep quality. Alternative Hypothesis (H1): SM has a significant effect on primary dysmenorrhea symptoms, pain severity, depression levels, and sleep quality. Researchers will compare three groups to determine if the combined intervention improves menstrual health: An intervention group receiving both CTM and SM applied to the abdominal and lumbar areas, A sham group receiving CTM with a sham SM procedure, A control group receiving no intervention. Participants will: Undergo three weekly sessions for one menstrual cycle (approximately three weeks), continuing for two cycles (six weeks total), Complete assessments on pain (VAS), menstrual symptoms (Menstrual Symptom Questionnaire), depression (Beck Depression Inventory), and sleep quality (Pittsburgh Sleep Quality Index) at the study's start and conclusion. This study aims to provide new insights into the combined effects of KDM and SM on menstrual health, potentially guiding future rehabilitation interventions for PD.

Conditions

Dysmenorrhea; Primary Dysmenorrhea

Keywords

Connective Tissue Massage; CTM; Spinal Manipulation; SP; Physiotherapy; Massage; Menstrual Pain; Rehabilitation; Complementary Therapy; Women's Health; Manual Therapy; Pain Relief

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale (VAS)

  The Visual Analog Scale (VAS) is a subjective measure used to assess the intensity of participants' pain. Participants are asked to indicate their perceived level of pain on a 10 cm line. One end of the line is marked as 0, indicating no pain, while the other end is marked as 10, representing unbearable pain. Participants were instructed to mark the intensity of pain experienced during the first three days of their initial menstrual period before joining the study, as well as during the last menstrual period at the end of the study, on three separate VAS lines, with the highest value recorded. The VAS is considered a valid and reliable tool for measuring experimental and clinical pain, demonstrating high sensitivity in detecting changes in clinical pain treatment and small variations in pain intensity.

  Baseline, post-intervention (approximately 6 weeks)

• Menstrual Symptom Questionnaire (MSQ)

  The Menstrual Symptom Questionnaire (MSQ) is a 22-item five-point Likert-type questionnaire developed by Chesney and Tasto (1975) to assess menstrual pain and symptoms. In 2014, Güvenç and colleagues adapted this questionnaire into Turkish, ensuring its validity. The questionnaire consists of three subscales: menstrual pain symptoms, negative effects/somatic complaints, and coping strategies. The questionnaire is scored between 22 and 110, with an increase in the average score indicating a greater severity of menstrual symptoms. The questionnaire was administered face-to-face to participants before and after the study, and their responses were recorded.

  Baseline, post-intervention (approximately 6 weeks)

Secondary Outcomes (2)

• Pittsburgh Sleep Quality Index (PSQI)

  Baseline, post-intervention (approximately 6 weeks)

• Beck Depression Inventory (BDI)

  Baseline, post-intervention (approximately 6 weeks)

Study Arms (3)

Manip

EXPERIMENTAL

Manip: Connective Tissue Massage (CTM) + Spinal Manipulation (SM) Participants in the CTM+SM group will be applied three times a week, starting from the predicted day of ovulation (cycle length minus 14 days) until the onset of the next menstrual period. This will include treatment of the pelvic regions, specifically the sacral, lumbar, lower thoracic, and anterior pelvic areas. In addition to the CTM, spinal manipulation will be performed. The manipulation will follow the CTM and will involve the application of high-velocity, low-amplitude (HVLA) force bilaterally to all clinically relevant vertebral levels from T10 to L5, as well as to the sacroiliac joints, accompanied by an audible release from one or more joints. Treatment will be administered three times a week, with each session lasting 20 minutes. This regimen will continue for a duration of six weeks.

Other: Connective Tissue Massage (CTM); Other: Spinal Manipulation

Sham Manip

SHAM COMPARATOR

Sham Manip: Connective Tissue Massage (CTM) + Sham Spinal Manipulation (Sham SM) The intervention will be applied three times a week, starting from the predicted day of ovulation (cycle length minus 14 days) until the onset of the next menstrual period. This will include treatment of the pelvic regions, specifically the sacral, lumbar, lower thoracic, and anterior pelvic areas. In addition to the CTM, sham spinal manipulation will be performed three times a week. This will involve the application of low-amplitude force bilaterally to all clinically relevant vertebral levels from T10 to L5 and to the sacroiliac joints, without producing any audible release. Treatment will be administered three times a week, with each session lasting 20 minutes. This regimen will continue for a duration of six weeks.

Other: Connective Tissue Massage (CTM); Other: Sham Spinal Manipulation

Control Group

NO INTERVENTION

Participants in this group will undergo an initial assessment during which general information about the study will be provided. They will be informed about the importance of refraining from taking any medications throughout the six-week study period. All participants will be re-evaluated after the completion of the six weeks.

Interventions

Connective Tissue Massage (CTM) OTHER

Connective Tissue Massage (CTM) was administered to the lumbar and abdominal regions by an experienced physiotherapist three times a week for 15 minutes over six weeks. The treatment started from the predicted day of ovulation (cycle length minus 14 days) until the onset of the next menstrual period. Both short and long strokes were utilized during CTM. Each stroke was repeated three times, first on the right side and then on the left side, across all manipulated areas. During the manipulation, the tip of the middle finger remained in contact with the patient's skin. The finger was positioned at a 45° angle, with the distal interphalangeal joint in flexion, and was moved to create traction. During the lumbar region treatment, participants were instructed to sit upright with their hips, knees, and ankles flexed at 90°, ensuring that their thighs and feet were fully supported. For the abdominal region treatment, participants lay supine with pillows placed under their head and knees.

Manip; Sham Manip

Spinal Manipulation OTHER

Spinal manipulation was performed by an experienced physiotherapist on the intervention group three times a week following Connective Tissue Massage (CTM). Participants in this group were positioned laterally, ensuring their lower leg remained straight and in contact with the treatment table. The contralateral or upper hip and knee were flexed and positioned so that they did not touch the table, allowing an unopposed force to be applied at the selected joint. Following CTM, manipulation was carried out with high-velocity, low-amplitude (HVLA) force applied bilaterally to all clinically relevant vertebral levels from T10 to L5 and the sacroiliac joints, accompanied by an audible sound from one or more joints.

Manip

Sham Spinal Manipulation OTHER

Sham spinal manipulation was administered by an experienced physiotherapist to the Sham Manipulation group three times a week following Connective Tissue Massage (CTM). In this group, participants were positioned laterally with their lower legs straight and in contact with the treatment table. The contralateral or upper hip and knee were flexed and positioned so that they did not touch the table, thereby allowing an unopposed force to be applied at the selected joint. Following CTM, low-amplitude force was applied bilaterally to all clinically relevant vertebral levels from T10 to L5 and the sacroiliac joints, without creating an audible sound.

Sham Manip

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only self-identified females are eligible to participate in this study, as it specifically addresses menstrual-related issues.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being 18 years or older,
• Having primary dysmenorrhea according to the criteria specified in the Primary Dysmenorrhea Consensus Guide (1. Onset of pain 6 to 24 months after menarche, 2. Pain lasting between 8 to 72 hours, and 3. The most intense pain occurring on the 1st and/or 2nd day of menstruation),
• Having a regular menstrual cycle (28 ± 7 days).

You may not qualify if:

• Having gastrointestinal, urogenital, autoimmune, or psychiatric disorders (serious psychiatric disorders that would prevent participation in the study),
• Having other chronic pain syndromes,
• Having given birth or a positive pregnancy test,
• Using an intrauterine device (IUD),
• Having undergone pelvic surgery,
• Having used chronic medications, including oral contraceptives or antidepressants, within at least 6 months prior to the study,
• Having irregular menstrual cycles (shorter than 21 days or longer than 35 days, and/or a cycle variation exceeding 4 days),
• Having a history of pathological conditions indicating secondary dysmenorrhea.

Sponsors & Collaborators

• Rustem Mustafaoglu: collaborator
• Istanbul University - Cerrahpasa: lead

Study Sites (2)

Istanbul University-Cerrahpasa

Istanbul, Istanbul, 34500, Turkey (Türkiye)

Location

IstanbulUC

Istanbul, Istanbul, 34500, Turkey (Türkiye)

Location

Related Publications (6)

• Hernandez-Diaz S, Garcia-Rodriguez LA. Epidemiologic assessment of the safety of conventional nonsteroidal anti-inflammatory drugs. Am J Med. 2001 Feb 19;110 Suppl 3A:20S-7S. doi: 10.1016/s0002-9343(00)00682-3.

  PMID: 11173046 BACKGROUND

• Hailemeskel S, Demissie A, Assefa N. Primary dysmenorrhea magnitude, associated risk factors, and its effect on academic performance: evidence from female university students in Ethiopia. Int J Womens Health. 2016 Sep 19;8:489-496. doi: 10.2147/IJWH.S112768. eCollection 2016.

  PMID: 27695366 BACKGROUND

• Eryilmaz G, Ozdemir F, Pasinlioglu T. Dysmenorrhea prevalence among adolescents in eastern Turkey: its effects on school performance and relationships with family and friends. J Pediatr Adolesc Gynecol. 2010 Oct;23(5):267-72. doi: 10.1016/j.jpag.2010.02.009. Epub 2010 May 21.

  PMID: 20493741 BACKGROUND

• Molins-Cubero S, Rodriguez-Blanco C, Oliva-Pascual-Vaca A, Heredia-Rizo AM, Bosca-Gandia JJ, Ricard F. Changes in pain perception after pelvis manipulation in women with primary dysmenorrhea: a randomized controlled trial. Pain Med. 2014 Sep;15(9):1455-63. doi: 10.1111/pme.12404. Epub 2014 Mar 25.

  PMID: 24666560 BACKGROUND

• Ozgul S, Uzelpasaci E, Orhan C, Baran E, Beksac MS, Akbayrak T. Short-term effects of connective tissue manipulation in women with primary dysmenorrhea: A randomized controlled trial. Complement Ther Clin Pract. 2018 Nov;33:1-6. doi: 10.1016/j.ctcp.2018.07.007. Epub 2018 Jul 21.

  PMID: 30396605 BACKGROUND

• Proctor M, Farquhar C. Diagnosis and management of dysmenorrhoea. BMJ. 2006 May 13;332(7550):1134-8. doi: 10.1136/bmj.332.7550.1134. No abstract available.

  PMID: 16690671 BACKGROUND

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Narges PIRI, Bcs

  Istanbul University-Cerrahpasa, Institute of Graduate Studies, Department of Physiotherapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Rüstem MUSTAFAOĞLU PT, PhD

  Istanbul University-Cerrahpasa, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT

Study Record Dates

• First Submitted: November 2, 2024
• First Posted: November 5, 2024
• Study Start: September 16, 2024
• Primary Completion: March 17, 2025
• Study Completion: March 17, 2025
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)